Amgen submits melanoma and cholesterol drugs to EMA

Regulator will assess talimogene laherparepvec and evolocumab

Amgen has filed two new drugs to the European Medicines Agency (EMA) for approval in the EU.

One of the drugs is talimogene laherparepvec, an oncology treatment that Amgen has submitted for use in the treatment of adults with metastatic melanoma.

Talimogene laherparepvec is one of several promising immunotherapies set to revolutionise cancer treatment over the next few years by triggering the body's immune system to fight tumour cells.

In the case of talimogene laherparepvec, the drug's method of action has been likened to a virus because when it is injected directly into a tumour it replicates causing the tumour cell to rupture and die in a process. The rupture of cancer cells also causes white blood cells to respond and to target the cancer.

The drug, which was acquired by Amgen as part of its takeover of BioVex, has shown promise as a treatment for the skin cancer melanoma during late stage trials that compared the drug to granulocyte-macrophage colony-stimulating factor (GM-CSF).

If approved, talimogene laherparepvec will enter what is likely to become a very competitive melanoma market for immunotherapy treatments.

In addition to the recently-launched Yervoy (ipilimumab) from Bristol-Myers Squibb (BMS), drugs currently either under review or in clinical trials for melanoma include Merck & Co's pembrolizumab, BMS' nivolumab, AstraZeneca's MEDI4736 and Merck Serono's MSB0010718C.

Evolocumab under review as cholesterol treatment

Amgen also announced it has submitted the antibody evolocumab for review as a treatment to reduce high levels of cholesterol.

The drug is part of a new class of cholesterol therapies known as PCSK9 inhibitors. Evolocumab is currently the most advanced of these treatments, although other promising prospects on the horizon include Pfizer's bococizumab and Sanofi/Regeneron's alirocumab.

All three drugs are expected to fulfil a medical unmet need by reducing low-density lipoprotein-cholesterol (LDL-c) in patients who cannot tolerate statins, such as Lipitor.

In addition to the European filings, Amgen has also submitted both talimogene laherparepvec and evolocumab for review by the US FDA in recent weeks.

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